Not currently registered with FDA under this name
Coltene AG
New York, NY, United States. Named as applicant on 15 dental 510(k) clearances between 1981 and 2004. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 151981–2004
- Markets registered in
- 225 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Coltene AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Coltene AG | 15 clearances | 1981–2004 | Below |
| South Korea | MFDS | Manufacturer | COLTENE AGColtene AG · COLTENE AG. · +1 | 25 | 1998–2003 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Coltene AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 May 2004 | K041098 | COOL TEMP NATURAL | EBG Resin Temporary Crown and Bridge |
| 18 Sep 2002 | K022224 | COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 28 Aug 1990 | K902392 | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL | EMA Dental Cement |
| 23 Sep 1988 | K882800 | COLTENE PRESIDENT JET REGULAR BODY | ELW Impression Material |
| 27 Oct 1987 | K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | EKS Endodontic Pulp Canal File |
| 27 Feb 1987 | K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | EBF Resin Tooth Shade Material |
| 29 Jan 1987 | K870047 | COLTENE RAPID | ELW Impression Material |
| 30 Oct 1986 | K863998 | COLTENE JET-MIXER | EID Restorative and Impression Material Syringe |
| 8 Feb 1985 | K850036 | COLTENE PRECISE | ELW Impression Material |
| 16 Mar 1984 | K840297 | COLTENE ORALLOY MAGICAPS | EJJ Amalgam Alloy |
| 15 Jul 1981 | K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | ELW Impression Material |
| 15 Jul 1981 | K811667 | COLTENE PRESSURE SPOT INDICATOR | ELW Impression Material |
| 15 Jul 1981 | K811666 | COLTENE COLTEX/COLTOFLAX | ELW Impression Material |
| 16 Jun 1981 | K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM | EBF Resin Tooth Shade Material |
| 23 Apr 1981 | K810907 | COLTENE ORALLY | EJJ Amalgam Alloy |
Some of these clearances are listed with FDA today by another company: Coltene/Whaledent AG (4).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.